|
Device |
nebulizer (direct patient interface) |
Product Code | CAF |
Regulation Number |
868.5630
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADHERIUM (NZ) LTD |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
AEROGEN LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIREHEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BREATHESUITE INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COGNITA LABS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN SIMZO ELECTRONIC TECHNOLOGY CO.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXCELLENTCARE MEDICAL (HUIZHOU) LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FEELLIFE HEALTH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBALCARE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HCMED INNOVATIONS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MANKIND PHARMA LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTIRES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROBASE TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MONAGHAN MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OCHSNER CLINIC FOUNDATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K223367 Ochsner Connected Inhaler Sensor
|
PARI RESPIRATORY EQUIPMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QINGDAO FUTURE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RECIPROCAL LABS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN HOMED MEDICAL DEVICE CO,.LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN HOMED MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN IVANKACA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THAYER MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE RITEDOSE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRUDELL MEDICAL INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VAPOTHERM INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|